ID

9673

Description

AMC-046 Adverse Events Form (ADV) Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7D8985E5-2E37-08A5-E040-BB89AD434A3B

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7D8985E5-2E37-08A5-E040-BB89AD434A3B

Keywords

Versions (4)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
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January 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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Anal Cancer NCT00550589 Toxicity - AMC-046 Adverse Events Form (ADV) - 2989394v1.0

English

Based on information entered, an AdEERS Report must be submitted. Please go to the CTEP website and access the AdEERS system

1 forms  
Header
Description

Header

CTC AE Category
Description

CTCAdverseEventCategory

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
CTC Adverse Event Term
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC Adverse Event Grade
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
Adverse Event Onset Date (mm/dd/yyyy)
Description

Adverse Event Onset Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985916
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25279
Unnamed2
Description

Unnamed2

MedDRA Code
Description

MedDRACode

Data type

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
If other CTC event selected, please provide description of event
Description

AdverseEventDescriptionText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Metathesaurus Property
C0678257
Was this event expected or anticipated
Description

AcquiredImmunodeficiencySyndromeClinicalTrialAdverseEventPredictionObservedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C2851
UMLS 2011AA ObjectClass-2
C0001175
NCI Thesaurus ObjectClass-3
C71104
UMLS 2011AA ObjectClass-3
C0008976
NCI Thesaurus Property
C25599
UMLS 2011AA Property
C1441672
NCI Thesaurus Property-2
C54156
UMLS 2011AA Property-2
C0681842
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Agent Name
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
CTC Adverse Event Attribution Code
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Alternative etiology
Description

AcquiredImmunodeficiencySyndromeAdverseEventAlternativeAttributionType

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C2851
UMLS 2011AA ObjectClass-2
C0001175
NCI Thesaurus Property
C25415
UMLS 2011AA Property
C1523987
NCI Thesaurus Property-2
C25358
UMLS 2011AA Property-2
C0596130
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Action Taken at Time of Adverse Event
Description

AcquiredImmunodeficiencySyndromeAdverseEventActionType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C2851
UMLS 2011AA ObjectClass-2
C0001175
NCI Thesaurus Property
C25404
UMLS 2011AA Property
C0441472
Other, specify
Description

AcquiredImmunodeficiencySyndromeAdverseEventActionSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C2851
UMLS 2011AA ObjectClass-2
C0001175
NCI Thesaurus Property
C25404
UMLS 2011AA Property
C0441472
If modification was made to study therapy, who initiated modification
Description

AcquiredImmunodeficiencySyndromeTherapyResponsiblePersonModificationType

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C2851
UMLS 2011AA ObjectClass
C0001175
NCI Thesaurus Property
C25657
UMLS 2011AA Property
C1273518
NCI Thesaurus Property-2
C25572
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Unnamed3
Description

Unnamed3

Outcome of Adverse Event
Description

AcquiredImmunodeficiencySyndromeAdverseEventOutcomeType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass-2
C2851
UMLS 2011AA ObjectClass-2
C0001175
AE Resolution Date (If "Resolved" mm/dd/yyyy)
Description

Adverse Event Resolution Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985918
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25655
If resolved with sequelae, specify
Description

AcquiredImmunodeficiencySyndromeAdverseEventResolvedwithSequelaeOutcomeSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C2851
UMLS 2011AA ObjectClass-2
C0001175
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C49495
UMLS 2011AA Property-2
C1709862
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Was this considered a Serious Adverse Event
Description

NationalCancerInstituteDefinitionSeriousAdverseEventPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C41335
UMLS 2011AA ObjectClass
C1519255
NCI Thesaurus ObjectClass-2
C19202
UMLS 2011AA ObjectClass-2
C1513882
NCI Thesaurus ObjectClass-3
C42777
UMLS 2011AA ObjectClass-3
C1704788
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Seriousness Attributed to Adverse Event (If "Yes" check "Yes" for all that apply Please note that checking "Yes" to any of the events below will require SAE notification according to protocol requirements.)
Description

AdverseEventSeriousnessAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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Similar models

Based on information entered, an AdEERS Report must be submitted. Please go to the CTEP website and access the AdEERS system

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
CTCAdverseEventCategory
Item
CTC AE Category
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
CTC Adverse Event Term
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Adverse Event Onset Date
Item
Adverse Event Onset Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C2985916 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C25279 (NCI Thesaurus Property)
Item Group
Unnamed2
MedDRACode
Item
MedDRA Code
float
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
AdverseEventDescriptionText
Item
If other CTC event selected, please provide description of event
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
AcquiredImmunodeficiencySyndromeClinicalTrialAdverseEventPredictionObservedInd-2
Item
Was this event expected or anticipated
boolean
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass-2)
C0001175 (UMLS 2011AA ObjectClass-2)
C71104 (NCI Thesaurus ObjectClass-3)
C0008976 (UMLS 2011AA ObjectClass-3)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C54156 (NCI Thesaurus Property-2)
C0681842 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Item
CTC Adverse Event Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.3
Code List
CTC Adverse Event Attribution Code
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (Unlikely)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
Item
Alternative etiology
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass-2)
C0001175 (UMLS 2011AA ObjectClass-2)
C25415 (NCI Thesaurus Property)
C1523987 (UMLS 2011AA Property)
C25358 (NCI Thesaurus Property-2)
C0596130 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.4
Code List
Alternative etiology
CL Item
None Apparent (None apparent)
CL Item
Study Disease (Study disease)
CL Item
Other Pre-existing Disease Or Condition (Other pre-existing disease or condition)
CL Item
Accident, Trauma, Or External Factors (Accident, trauma, or external factors)
CL Item
Concurrent Illness/condition (not Pre-existing) (Concurrent illness/condition (not pre-existing))
Item
Action Taken at Time of Adverse Event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass-2)
C0001175 (UMLS 2011AA ObjectClass-2)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS 2011AA Property)
CL.5
Code List
Action Taken at Time of Adverse Event
CL Item
Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)
CL Item
Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)
CL Item
Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)
CL Item
Prescription (Prescription)
C28180 (NCI Thesaurus)
C1521941 (UMLS 2011AA)
CL Item
Otc/non-rx (OTC/non-Rx)
CL Item
Hospitalization For Ae (Hospitalization)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AcquiredImmunodeficiencySyndromeAdverseEventActionSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass-2)
C0001175 (UMLS 2011AA ObjectClass-2)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS 2011AA Property)
Item
If modification was made to study therapy, who initiated modification
text
C15368 (NCI Thesaurus ObjectClass)
C2851 (NCI Thesaurus ObjectClass-2)
C0001175 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus Property)
C1273518 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.6
Code List
If modification was made to study therapy, who initiated modification
CL Item
Patient Initiated (Patient initiated)
CL Item
Physician Initiated (Physician initiated)
Item Group
Unnamed3
Item
Outcome of Adverse Event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2851 (NCI Thesaurus ObjectClass-2)
C0001175 (UMLS 2011AA ObjectClass-2)
CL.7
Code List
Outcome of Adverse Event
CL Item
Adverse Event Is Resolved (Resolved)
CL Item
Adverse Event Is Resolved With Sequelae (Resolved with sequelae)
CL Item
Unresolved, Protocol Ongoing (Unresolved, protocol ongoing)
CL Item
Unresolved At Protocol Completion (Unresolved at protocol completion)
Adverse Event Resolution Date
Item
AE Resolution Date (If "Resolved" mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C2985918 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C25655 (NCI Thesaurus Property)
AcquiredImmunodeficiencySyndromeAdverseEventResolvedwithSequelaeOutcomeSpecify
Item
If resolved with sequelae, specify
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass-2)
C0001175 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C49495 (NCI Thesaurus Property-2)
C1709862 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
NationalCancerInstituteDefinitionSeriousAdverseEventPresentInd-2
Item
Was this considered a Serious Adverse Event
boolean
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
C19202 (NCI Thesaurus ObjectClass-2)
C1513882 (UMLS 2011AA ObjectClass-2)
C42777 (NCI Thesaurus ObjectClass-3)
C1704788 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Seriousness Attributed to Adverse Event (If "Yes" check "Yes" for all that apply Please note that checking "Yes" to any of the events below will require SAE notification according to protocol requirements.)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
CL.9
Code List
Seriousness Attributed to Adverse Event (If "Yes" check "Yes" for all that apply Please note that checking "Yes" to any of the events below will require SAE notification according to protocol requirements.)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Life Threatening (Life threatening)
CL Item
Disability (Disability/incapacity)
C21007 (NCI Thesaurus)
C0231170 (UMLS 2011AA)
CL Item
Congenital Anomaly (Congenital anomaly)
CL Item
Intervention Required (Required intervention to prevent permanent impairment/damage)
CL Item
Hospitalized (Hospitalization, initial or prolonged)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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